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The Titanium-TSY™ Shoulder Plate Implant is intended to stabilize a bone graft within the humeral head and neck to assist healing of an intraosseous fracture.

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The provided text describes a 510(k) premarket notification for a medical device, the "Titanium-TSYTM Shoulder Plate Implant." This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with strict acceptance criteria and performance studies like those often associated with novel high-risk devices or software.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, and MRMC studies is not explicitly available in the provided document. The 510(k) summary focuses on administrative information, device description, predicate device identification, and intended use to establish substantial equivalence.

Here's an explanation based on the provided text, addressing why certain information is absent and what can be inferred:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated. For a 510(k) submission, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a predicate device. This typically involves showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to the predicate.
• Reported Device Performance: No specific performance metrics (e.g., success rates, complication rates, mechanical strength values) are reported in this summary. The substantial equivalence argument implies similar performance to the predicate.

2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

• Test Set Sample Size & Data Provenance: Not applicable and not mentioned. 510(k) submissions typically do not involve a "test set" in the sense of a clinical trial for performance evaluation. Substantial equivalence is often demonstrated through bench testing (for mechanical properties, biocompatibility), materials comparison, and comparison of design features to the predicate. No clinical data (prospective or retrospective) is presented here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

• Experts & Qualifications for Ground Truth: Not applicable and not mentioned. Since there isn't a "test set" with clinical outcomes requiring expert interpretation for ground truth, such information is not part of this 510(k) summary.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Adjudication Method: Not applicable and not mentioned for the same reasons as #3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• MRMC Study: Not applicable. This device is a bone plate implant, a mechanical orthopedic device, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Standalone Performance: Not applicable. As mentioned, this is a mechanical implant, not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Type of Ground Truth: Not applicable. The "ground truth" for a 510(k) is effectively the safety and effectiveness of the predicate device (TSYTM Shoulder Plate Implant, K040850). The new device aims to be substantially equivalent to that established "truth."

8. The sample size for the training set:

• Training Set Sample Size: Not applicable. This device does not involve machine learning or AI that would require a "training set."

9. How the ground truth for the training set was established:

• Ground Truth for Training Set: Not applicable for the same reasons as #8.

Summary based on the document:

The provided document is a 510(k) summary for the "Titanium-TSYTM Shoulder Plate Implant." The basis of its acceptance and clearance by the FDA is substantial equivalence to a previously cleared predicate device, the TSYTM Shoulder Plate Implant (K040850), cleared on June 24, 2004.

The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This means the "study" that proves the device meets "acceptance criteria" is the comparison to the predicate device focusing on:

• Intended Use: The Titanium-TSYTM Shoulder Plate Implant is intended to stabilize a bone graft within the humeral head and neck to assist healing of an intraosseous fracture. This is the same intended use as the predicate.
• Technological Characteristics: While not detailed in this summary, a 510(k) submission would typically include comparisons of materials (titanium vs. whatever the predicate was made of, ensuring biocompatibility), design features, and possibly bench testing to demonstrate similar mechanical performance and safety profiles. The name itself, "Titanium-TSYTM," suggests a material change from the predicate "TSYTM Shoulder Plate Implant."

Without the full 510(k) submission, specific details of the comparison (e.g., mechanical test results, detailed material specifications) are not available. However, the FDA's clearance indicates that the submitted information was sufficient to demonstrate substantial equivalence and meet the regulatory requirements for Class II devices.

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